EP3998992B1 - Unabhängige betätigungsverfahren für proximale elemente - Google Patents

Unabhängige betätigungsverfahren für proximale elemente

Info

Publication number
EP3998992B1
EP3998992B1 EP20750122.2A EP20750122A EP3998992B1 EP 3998992 B1 EP3998992 B1 EP 3998992B1 EP 20750122 A EP20750122 A EP 20750122A EP 3998992 B1 EP3998992 B1 EP 3998992B1
Authority
EP
European Patent Office
Prior art keywords
proximal element
proximal
element line
handle
catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20750122.2A
Other languages
English (en)
French (fr)
Other versions
EP3998992A1 (de
Inventor
Koji KIZUKA
Richard Childs
Gabriel Gonzales
Dylan VAN HOVEN
Chad Abunassar
Travis Marsot
Nisu PATEL
Rob MOSLEY
Francisco VALENCIA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Evalve Inc
Original Assignee
Evalve Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Evalve Inc filed Critical Evalve Inc
Priority to EP25212384.9A priority Critical patent/EP4663166A3/de
Publication of EP3998992A1 publication Critical patent/EP3998992A1/de
Application granted granted Critical
Publication of EP3998992B1 publication Critical patent/EP3998992B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Claims (15)

  1. Fixierungssystem zur Fixierung von Segeln einer Herzklappe, umfassend:
    eine implantierbare Fixierungsvorrichtung, umfassend
    einen ersten Arm (18A) und einen zweiten Arm (18B),
    ein erstes proximales Element (16A), das relativ zum ersten Arm (18A) zwischen einer ersten Position und einer zweiten Position beweglich ist, und
    ein zweites proximales Element (18B), das relativ zum zweiten Arm (18B) zwischen einer ersten Position und einer zweiten Position beweglich ist; und
    eine Zuführvorrichtung, umfassend
    einen Katheter (86) mit einem proximalen Endabschnitt und einem distalen Endabschnitt, wobei der Katheter mindestens ein Lumen definiert, das sich zwischen dem proximalen Endabschnitt und dem distalen Endabschnitt erstreckt,
    eine erste proximale Elementlinie (90A), die sich durch das mindestens eine Lumen erstreckt, wobei die erste proximale Elementlinie (90A) lösbar an das erste proximale Element (16A) gekoppelt ist und betätigt werden kann, um das erste proximale Element (16A) zwischen der ersten Position und der zweiten Position zu bewegen,
    eine zweite proximale Elementlinie (90B), die sich durch das mindestens eine Lumen erstreckt, wobei die zweite proximale Elementlinie (90B) lösbar an das zweite proximale Element (16B) gekoppelt ist und betätigt werden kann, um das zweite proximale Element (16B) zwischen der ersten Position und der zweiten Position zu bewegen; und
    einen Griff (393) mit
    einem Griff der ersten proximalen Elementlinie (393A), der an die erste proximale Elementlinie (90A) gekoppelt ist und betätigt werden kann, um diese einzusetzen, um das erste proximale Element (16A) zwischen der ersten Position und der zweiten Position zu bewegen,
    einen Griff der zweiten proximalen Elementlinie (393B), der an die zweite proximale Elementlinie (90B) gekoppelt ist und betätigt werden kann, um diese einzusetzen, um das zweite proximale Element (16B) zwischen der ersten Position und der zweiten Position zu bewegen; und
    eine Verriegelung (1610), die zwischen einer entriegelten Position, in der der Griff der ersten (393A) und zweiten (393A) proximalen Elementlinie unabhängig betätigt werden können, und einer verriegelten Position, in der der der Griff der ersten (393A) und zweiten (393B) proximalen Elementlinie zusammengekoppelt sind, um gemeinsam betätigt werden zu können, beweglich sind,
    wobei die Verriegelung (1610) einen Riegel (1611), der beweglich an den Griff der ersten proximalen Elementlinie (393A) gekoppelt ist, und eine Vertiefung (1612) umfasst, die im Griff der zweiten proximalen Elementlinie (393B) angeordnet ist.
  2. Fixierungssystem nach Anspruch 1, wobei der Griff der ersten proximalen Elementlinie (393A) und der Griff der zweiten proximalen Elementlinie (393B) parallel ausgerichtet sind.
  3. Fixierungssystem nach Anspruch 1, wobei der Griff der ersten proximalen Elementlinie (393A) und der Griff der zweiten proximalen Elementlinie (393B) koaxial ausgerichtet sind.
  4. Fixierungssystem nach Anspruch 1, wobei der Griff der ersten proximalen Elementlinie (393A) und der Griff der zweiten proximalen Elementlinie (393B) jeweils einen drehbaren Schalter umfasst.
  5. Fixierungssystem nach Anspruch 1, wobei der Griff (393) ferner einen ersten Anschlag umfasst, um eine Distanz einzuschränken, in der jeder aus dem Griff der ersten proximalen Elementlinie (393A) und Griff der zweiten proximalen Elementlinie (393B) in eine erste Richtung bewegt werden kann.
  6. Fixierungssystem nach Anspruch 1, wobei der Griff (393) ferner einen zweiten Anschlag umfasst, um eine Distanz einzuschränken, in der jeder aus dem Griff der ersten proximalen Elementlinie (393A) und Griff der zweiten proximalen Elementlinie (393B) in eine zweite Richtung bewegt werden kann.
  7. Fixierungssystem nach Anspruch 1, wobei die Verriegelung einen Schieberverriegelungsmechanismus beinhaltet.
  8. Fixierungssystem nach Anspruch 1, wobei die Verriegelung einen Drehverriegelungsmechanismus beinhaltet.
  9. Fixierungssystem nach Anspruch 1, wobei der Riegel und die Vertiefung komplementäre Schwalbenschwanzformen (1613) umfassen.
  10. Fixierungssystem nach Anspruch 9, wobei die Schwalbenschwanzformen (1613) asymmetrisch sind.
  11. Fixierungssystem nach Anspruch 1, wobei der Riegel (1611) eine Falle (1611C) umfasst, die in einer ersten Arretierung (1617A) in dem Griff der ersten proximalen Elementlinie (393A) aufgenommen werden kann, um den Riegel (1611) in der entriegelten Position zu halten, und die in einer zweiten Arretierung (1617B) in dem Griff der ersten proximalen Elementlinie (393A) aufgenommen werden kann, um den Riegel (1611) in der verriegelten Position zu halten.
  12. Fixierungssystem nach Anspruch 11, wobei die Falle (1611C) an einem Auslegerarm (1611D) angeordnet ist.
  13. Fixierungssystem nach Anspruch 1, wobei die Verriegelung (1610) eine abnehmbare Klammer (1616) beinhaltet.
  14. Fixierungssystem nach Anspruch 1, wobei mindestens einer aus dem Griff der ersten proximalen Elementlinie (393A) und dem Griff der zweiten proximalen Elementlinie (393B) eine taktile Anzeige (1628) umfasst.
  15. Fixierungssystem nach Anspruch 1, wobei der erste Arm (18A) und das erste proximale Element (16A) auf einer ersten Seite der implantierbaren Fixierungsvorrichtung (14) angeordnet sind, und der zweite Arm (18A) und das zweite proximale Element (16B) auf einer zweiten Seite der implantierbaren Fixierungsvorrichtung (14) angeordnet sind,
    wobei die erste Seite eine Echogenität aufweist, die anders als die Echogenität der zweiten Seite ist.
EP20750122.2A 2019-07-15 2020-07-15 Unabhängige betätigungsverfahren für proximale elemente Active EP3998992B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP25212384.9A EP4663166A3 (de) 2019-07-15 2020-07-15 Unabhängige proximale elementbetätigungsverfahren

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962874327P 2019-07-15 2019-07-15
US201962930948P 2019-11-05 2019-11-05
PCT/US2020/042137 WO2021011653A1 (en) 2019-07-15 2020-07-15 Independent proximal element actuation methods

Related Child Applications (2)

Application Number Title Priority Date Filing Date
EP25212384.9A Division EP4663166A3 (de) 2019-07-15 2020-07-15 Unabhängige proximale elementbetätigungsverfahren
EP25212384.9A Division-Into EP4663166A3 (de) 2019-07-15 2020-07-15 Unabhängige proximale elementbetätigungsverfahren

Publications (2)

Publication Number Publication Date
EP3998992A1 EP3998992A1 (de) 2022-05-25
EP3998992B1 true EP3998992B1 (de) 2026-03-18

Family

ID=71895291

Family Applications (2)

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EP25212384.9A Pending EP4663166A3 (de) 2019-07-15 2020-07-15 Unabhängige proximale elementbetätigungsverfahren
EP20750122.2A Active EP3998992B1 (de) 2019-07-15 2020-07-15 Unabhängige betätigungsverfahren für proximale elemente

Family Applications Before (1)

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Country Status (6)

Country Link
US (2) US12048624B2 (de)
EP (2) EP4663166A3 (de)
JP (1) JP7543391B2 (de)
CN (2) CN121196804A (de)
CA (1) CA3147583C (de)
WO (1) WO2021011653A1 (de)

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EP4618905A1 (de) 2022-11-18 2025-09-24 Evalve, Inc. Befestigungsvorrichtung mit symmetrischen verlängerungselementen
CN118267160A (zh) * 2022-12-29 2024-07-02 杭州德晋医疗科技有限公司 组织夹持装置及组织夹持系统
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